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FDA to provide independent review for Wright Medical, FzioMed products

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The FDA elected to provide independent review on Wright Medical’s Augment Bone Graft and FzioMed’s Oxiplex Gel, both of which received not approvable letters earlier this year.

The FDA will convene a Dispute Resolution Panel to provide advice to the Commissioner on complex or contested scientific issues between the FDA and medical device sponsors, applicants or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by the FDA and agency guidance and policies, according to a press release.

“We appreciate the FDA’s willingness to grant our request to convene a Dispute Resolution Panel in connection with our appeal of the not approvable decision for Augment Bone Graft,” Robert Palmisano, president and chief executive officer of Wright Medical, stated in the release. “We look forward to working with the FDA to schedule the panel meeting as soon as possible.”

“We commend the FDA for granting our petition for reconsideration, a rarely used part of the regulatory process that companies can pursue when their device application is denied by the FDA,” John Krelle, president and chief executive officer of FzioMed, stated in the release. “The totality of data from the various studies submitted to FDA on Oxiplex, representing approximately 500 patients studied over nearly a decade, combined with extensive clinical success achieved outside the United States, demonstrate that Oxiplex can offer increased effectiveness compared to spine surgery alone, while presenting no significant safety risk.”